|Senior Medical Writer|
|US - Home or Office Based|
We are seeking a Medical Writer/Senior Medical Writer to join our team based here in the US. This position can be either office based from one of our locations on the East Coast or a remote position can also be considered.
At Cytel we believe the clinical development of safe and effective medicines is crucial for human welfare. Our mission is to improve success rates in this endeavor via the optimal design, effective implementation and accurate data management of clinical trials.
The Medical Writer independently prepares documents necessary for all phases of clinical drug development by organizing, analyzing, and interpreting scientific and statistical data. Such documents include, but are not limited to, clinical study reports, study protocols, investigator’s brochures, clinical summaries, briefing books and responses to authorities, abstracts and manuscripts.
• Works with Project Manager to develop timelines and resource plans for the production of clinical study reports and filings to regulatory authorities.
• Reviews statistical analysis plans, summary table shells, and case report forms as required.
• Performs quality control (QC) review of clinical study reports, and clinical sections of regulatory submissions
Qualifications and Experience:
Minimum Education: BS/BSc/BA in a science or industry-related discipline.
Work Requirements: Minimum of 5 years of medical writing experience in a contract research organization (CRO), pharmaceutical, or biotech setting.
Skills: Working knowledge of ICH and other regulatory guidelines. Broad knowledge of global pharmaceutical regulatory requirements, and experience in clinical research or other areas of the pharmaceutical industry. The ability to accurately and clearly present clinical data as well as strong verbal and interpersonal communication skills. Fluency in English (spoken and written) is required. Excellent writing (e.g., English usage) and a keen attention to detail also are required. Proficiency in Microsoft Word and graphic presentations is required. A degree of experience in using e-submission systems.
Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.
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